A person-centred care transition support for people with stroke/TIA: A study protocol for effect and process evaluation using a non-randomised controlled design

Introduction Care transitions following a stroke call for integrated care approaches to reduce death and disability. The proposed research described in this study protocol aims to evaluate the effectiveness of a person-centred multicomponent care transition support and the process in terms of contextual moderators, implementation aspects and mechanisms of impact. Methods A non-randomized controlled trial design will be used. The intervention includes person-centred dialogue intended to permeate all patient-provider communication, various pedagogical modes of information, a person-centred care and rehabilitation plan, and a bridging e-meeting to prepare patients for homecoming. Patients with stroke or TIA who are to be discharged from the participating hospitals to home and referred to a neurorehabilitation team for continued rehabilitation will be included. Follow-ups will be conducted at one week, 3 months and 12 months. Data will be collected on the primary outcome of perceived quality of the care transition, and on the secondary outcomes of health literacy, medication adherence, and perceived person-centeredness. Data for process evaluation will be collected through semi-structured interviews, focus groups, participatory observations, and the Normalisation Measure Development Questionnaire. Discussion The study will provide insights on implementation, mechanisms of impact, contextual moderators, and effectiveness of a care transition support, targeting a poorly functioning part of the care trajectory for people with stroke and TIA. Clinical trial registration ClinicalTrials.gov Identifier: NCT05646589.


Theoretical framework
As this co-designed multi-component care transition intervention includes coordination of care with focus on patient understanding of health information, we rely on two different frameworks: person-centred integrated care and social cognitive theory.
The project adheres to the person-centred Rainbow model of integrated care 4 , on micro and meso level.Integrated care entails that the intervention is based on the individual's preferences, needs, and values, taking patient resources into consideration, i.e., is personcentred 5 .This model emphasizes the need for both functional and normative links between patients and healthcare professionals, as well as within and between hospitals and the primary care organizations.Functional here refers to the information systems linking the hospital and primary care organizations together.Normative here refers to shared understanding and values, both within and between organizations, including taking patients' various needs and perspectives into consideration.
Health literacy emerges from theories of social exchange and social cognitive theory 6 ).Social cognitive theory in turn was first known as social learning theory focusing on the principles of learning within social contexts; through the addition on "cognition" a focus on human information processing capacities that influence learning was recognized 7 .Social cognitive theory emphasizes the dynamic interplay between personal, behavioral, and environmental influences 7 .An individual's capacity to manage one's health depends on e.g., language, trust, and context of the communication situation.Effective communication is therefore crucial to enable patients to make informed decisions regarding their health condition and self-management.In this project, we will draw upon social cognitive theory in our focus on the interplay between patients and healthcare professionals for patient information processing capacity.Following social cognitive theory, we conclude that patients' self-management of secondary preventive medication is dependent on the individual professionals' communication skills.

Background
The present project focuses on people who recently have had a stroke or TIA as: 1) they represent a large group, 2) the majority are older people, living at home, who are especially vulnerable in care transitions, 3) the disabilities that follow a stroke such as cognitive and communicative barriers can make handling information particularly challenging.
Stroke is a life-threating condition that needs acute treatment 8 .Strong evidence has shown that stroke care should initially be supplied in hospital stroke units 9 .Sweden is considered to have an efficient medical acute stroke care 10 with very short hospitalizations.Thus, the stroke chain of care always implies a care transition from inpatient care to primary care, i.e., a shift in responsibility from one healthcare setting to another.Uncoordinated care transitions impose a burden to patients and their significant others, especially when patients and significant others lack information on how to navigate the healthcare system 8 .Cognitive impairments, post-stroke fatigue and depression 11 , as well as the sudden onset of stroke and TIA, often render the patient and their significant others unprepared for the care transition to their home 12,13 .In addition, the short hospital stay leaves little time to participate in transition planning 1,2 , leading to a sense of being abandoned to a new and complex life situation after discharge 2 .Swedish law requires care providers to coordinate care.Nevertheless, a great responsibility during transitions is put on the patient and significant others to coordinate the care transition 14 .Few arrangements are offered to support the patient's own ability to participate in their care or to self-manage after discharge 15,16 .
There is a gap between the information provided by healthcare professionals and the information patients understand and can apply.Although 90% of recently discharged older people stated that they had understood the discharge information, 40% could not recall their diagnosis 17 , 62% their new medications 18 and 23% their healthcare plan 17 .As all persons who have had a stroke receive new or revised medications, patient understanding is required not only about what new medications they have received, but also on why and how these medications are to be taken and which care provider that is responsible for medication follow-up 8,19 .Such medication management is one key task in patient self-management 20 .Self-management of secondary stroke preventive medications is crucial, as recurrent strokes account for 21% of all strokes 19 and stroke is the leading cause of disability 21 .Despite the importance of continuous medication adherence, the medical follow-up does not occur until several months after discharge 19 .This means that if a person did not understand the information at hospital, they are at risk of medication non-adherence and of getting a new stroke.Hence, in each patient-provider meeting at hospital, it is critical to ensure that patients understand the health information to enable self-management of medications.
Patient understanding of information needed for self-management means a person's "ability to gain access to, understand and use information in ways that promote and maintain good health" 22 .This ability has been defined by WHO as health literacy 22 .WHO emphasizes that health literacy do not only depend on the individuals' ability but equally important on the capacity of healthcare organizations to provide services that support the patients' ability 23 .Low health literacy which is common after stroke 24 is associated with reduced adherence to medical advice, greater healthcare utilization, and among older persons overall poorer health status and higher mortality 25 .Thus, it has been strongly suggested that to enhance selfmanagement after stroke healthcare services should be tailored to meet patients' varying levels of health literacy 26 .To improve patients' self-management of secondary prevention, a recent systematic review concluded that "future research should focus on the development of more effective interventions to translate secondary prevention recommendations into practice" 27 .
Therefore, this project translates the intention of the Patient Law; the recommendations of the national person-centred and cohesive care process for stroke and TIA; and recommendations for secondary prevention into a multicomponent intervention co-designed to fit in practice and tailored to patient needs.

The intervention
The intervention has been co-designed by the users of this intervention, i.e., patients, significant others, and healthcare professionals.We also based the intervention on results from our pre-studies 1,2 and literature [28][29][30] .The intervention was developed with the intention to be realistic regarding what can be provided by the healthcare professionals in the involved organisational settings while focusing on patient perspective.This multi-component intervention targets how healthcare professionals can improve quality with care transition and support health literacy for self-management of secondary prevention for persons who are to be discharged from hospitals after stroke and TIA.The intervention includes communication of "what matters to me", i.e., what is important for the individual patient; and a bridging e-meeting to prepare patients for home-coming.The bridging emeeting before discharge includes the patient, their significant other, professionals at hospital and the home-rehabilitation teams in primary care (neuroteam).The intervention also includes various pedagogical modes of information; and a structured discharge letter on secondary preventive medications, the health condition, and plans for follow-ups at the discharge encounter.In all patient-provider communication (i.e., including provision of information), the person-centred communication method "Teach back" 31,32 is applied to ensure patient understanding of information; a structured communication channel between hospital staff and neuroteams.

Preliminary and previous results
The project is a continuation of a since 2016 ongoing project, funded by Kamprad Foundation, Neuro Sweden, and the Swedish Stroke Association.In these pre-studies, we explored current state of procedures and processes during care transitions to home; needs and experiences by people with stroke, significant others, and healthcare professionals 1,2 ; and patients' and significant others' outcomes (unpublished).Based on these results, we conducted a co-design process 33 in which we developed the multi-component care transition intervention presented in Figure 1 above.The intervention has been tested in a feasibility study and assessed as feasible to conduct.
In the pre-studies and in the feasibility testing, we used the same methods of inclusion of patients and significant others, and of data collection as proposed in this application.We are therefore confident that the proposed methods are well suitable for the patient and significant other population.

Significance and scientific novelty
Despite the good intentions in the Patient Law and the person-centred and cohesive care process, these are not easily implemented in clinical practice.The here proposed intervention is an operationalization of these regulations that has been developed in a codesign process including patients, significant others, and professionals at Danderyd hospital and in primary care rehabilitation teams (neuroteams).The intervention has been further refined together with the professionals for one year to be tailored to fit into organizational settings and to be practical and applicable.The co-design process was purposefully employed to make sure that the intervention being developed accurately reflected the priorities and opinions of the targeted user group.
The originality of this proposal is that the intervention covers both functional and normative links 4 of the care transition, i.e., is multi-component, to improve satisfaction with care transitions, health literacy, and medication adherence after stroke and TIA.The multicomponent intervention targets communication between patients and professionals, and between care units, as well as allowing for flexibility and person-centered approach to the heterogenous needs of this especially vulnerable group of people.It aims to increase quality with care transitions and support patient health literacy through cross-organizational collaboration and pedagogical methods of information.In all intervention components, the person-centred communication method Teach back will be used.The use of Teach Back has been shown to reduce number of hospital readmissions and improve medication adherence and self-management for people with chronic conditions 31,32 .Despite positive effects, there is only one previous study of Teach Back in Sweden 34 and no studies on Teach Back in stroke care nationally or internationally.Further, health literacy is context dependent, i.e., also persons with high levels of education can have low health literacy due to illness, shock, and unfamiliarity with healthcare.Projects focusing on health literacy is hence especially important for older people with stroke due to the sudden onset, the cognitive and communicative consequences, and as neglect of self-management of secondary prevention is life threatening.

Methods
The project adheres to the Medical Research Council framework of complex interventions 35 , which calls for phased and iterative approaches in the design and evaluation.The intervention was developed based on our pre-studies 1,2 , care transition literature [28][29][30] , and in a co-design process 36 .
We will apply a non-randomized controlled trial design, which is well suited for complex interventions to assess intervention effectiveness.Randomization on patient level is not suitable, due to the risk of contamination.We have assessed that professionals in the same unit cannot separate and use different approaches for control and intervention patients.Further, the use of a non-randomized controlled trial design makes it possible to consider the role of context and the complexity of transitional care during implementation and in the evaluation.With complexity of transitional care, we acknowledge that the intervention involves communication and interaction between different professions in multiple settings (different wards at different hospitals and neuroteams of various sizes and organizational forms), as well as persons with various needs.Such complexity, defined as a "dynamic and constantly emerging set of processes and objects that not only interact with each other, but come to be defined by those interactions" 37 calls for new approaches to evaluate impact.We conclude that the complex, dynamic system of care transitions has outgrown the use of conventional scientific methods and we must apply methods that best deal with uncertainty, unpredictability, and generative causality 38 .We will therefore use a research design of one intervention site and one control site, including multiple follow-ups over one year 39 and in two phases focus on evaluation of effect and on process evaluation.

PHASE 1: EVALUATION OF EFFECT
RQ1: Does a multi-component care transition intervention have an effect on functioning, perceived quality with care transitions, health literacy, medication adherence, perceived person-centeredness, recurrent stroke/TIA, healthcare utilization, and collected medications?Design Non-randomized controlled trial.The intervention will be implemented at geriatric stroke wards and acute stroke units at one hospital, and the corresponding neuroteams in primary care.Geriatric stroke wards and acute stroke units at one other hospital will serve as controls.

Participants
Patients: We will include patients who have had a first time ever or recurrent stroke or TIA; who are to be discharged from the participating hospitals to home and referred to a neuroteam for continued rehabilitation; and who are able to give informed consent by themselves.The patients will be informed of the study and invited to participate at the hospitals by a research assistant.The research assistant will provide oral and written information about the study and obtain consent to participate.Significant others.Significant others will be included via the included patients.The included patients will be asked about their willingness to name a significant other for invitation to also participate in the study.The significant others will be mailed written information about the study including an informed consent and a pre-stamped envelope.Significant others who return a signed consent will be included in the study.Patients who do not have or do not want to name a significant other, will remain included in the study without a significant other.

Data collection
The data will be collected using questionnaires through a study specific protocol.
Patient data: Baseline: After written consent, sociodemographic and disease-related data (e.g., stroke severity, co-morbidities) will be collected from hospital records and questionnaires.Data on patient functioning will be collected in structured interviews.Cognitive function will be assessed using Montreal Cognitive Assessment (MOCA), depression using Patient Health Questionnaire (PHQ-2), activities of daily living using Barthel Index, recovery after stroke using a visual analogue scale, level of disability using modified Ranking Scale (mRS), and walking ability using a single-item question.This baseline data will be collected by the data collectors/research assistant.
One-two weeks after discharge, data will be collected on the primary outcome quality with care transitions using the Care Transition Measure (CTM).We will also assess health literacy using the health literacy questionnaire (HLQ), the Stroke Patient Education Retention questionnaire (SPER) and health literacy survey (HLS), medication adherence using the Medication Adherence Report Scale (MARS), perceived person-centeredness using the General person-centered care questionnaire (GPCC-Q), patient activation using the Patient activation measure (PAM), fatigue using a visual analogue scale, depression using PHQ-2, stroke severity using the modified ranking scale (mRS); activities of daily living using Barthel Index, and recovery after stroke.We will thereto ask patients about any received new or changed prescribed medications after discharge; and perceived met needs of care and rehabilitation.
At 3 and 12 months, data will be collected on health literacy using HLQ, HLS, and SPER, medication adherence using the Medication Adherence Report Scale (MARS), perceived person-centeredness using the General person-centered care questionnaire (GPCC-Q), patient activation using the Patient activation measure (PAM), fatigue using a visual analogue scale, depression using PHQ-2, stroke severity using the modified ranking scale (mRS); activities of daily living using Barthel Index, recovery after stroke, and cognitive function using MOCA.We will thereto ask patients about any received new or changed prescribed medications after discharge; and perceived met needs of care and rehabilitation.
At 12 months, data on number of recurrent strokes, unplanned hospitalizations and collected medications during the first year after stroke from Region Stockholm's database (VAL) will be collected.
Three measures of health literacy will be used to allow for psychometric evaluation.
Significant other data: After written consent, sociodemographic data, relation to the patient, home-help service, life satisfaction, information received, informal care supplied, and selfrated health will be collected through a study specific protocol; and data on caregiver burden 40 , and health literacy using the HLQ using questionnaires in structured interviews.Data will be collected at 1-4 weeks, 3 and 12 months post patient discharge.

Sample size
Results from our pre-studies show that participants had a mean of 62 points in the care transition measure and standard deviation 21.Based on the estimation that satisfaction will be a mean of 72 in the new developed multi-component care transition we will need to recruit 70 patients (80% power, p=0.05, 2 sided).Allowing for 20% drop-out we will need to recruit in total 84 patients per group.Allowing for the intervention being conducted at two sites per hospital, we may need 168 patients per group, i.e., 336.

Analyses
Patients in the intervention group will be compared to control group using intention-to-treat and per-protocol analysis.Regression models adjusting for covariates (e.g., age, gender, stroke severity, and other disease-related data) will be used for analyses of primary and secondary outcomes.